Geniculate Artery Embolization for the Treatment of Knee Pain
| Status: | Completed |
|---|---|
| Conditions: | Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 8/25/2018 |
| Start Date: | January 25, 2017 |
| End Date: | August 3, 2018 |
Geniculate Artery Embolization for the Treatment of Knee Pain Secondary to Osteoarthritis
This study is to test a new treatment method, geniculate artery embolization (GAE), to reduce
the severity of pain and disability caused by knee osteoarthritis.
the severity of pain and disability caused by knee osteoarthritis.
Purpose: The primary aims of this study are to determine if geniculate artery embolization
(GAE) will reduce the severity of pain as well as global disability (resulting from the
combination of pain, stiffness and difficulty performing daily activities) caused by knee OA
and if it can be performed safely. The secondary aim is to determine if GAE can result in the
decreased necessity for ongoing conservative OA therapies such as medication therapy and
joint injections.
Participants: Twenty patients with knee osteoarthritis resulting in knee pain that is
refractory to conservative therapies, who are not planning to undergo surgery within 6
months.
Procedures (methods): This will be an open label 24-month pilot study with a small population
undergoing GAE to determine safety and efficacy. Clinical procedures and evaluations will
consist of a preoperative screening assessment to determine if the potential study subject
meets the inclusion and exclusion criteria, enrollment, surgical procedure for geniculate
artery embolization, and follow-up visits at 24 hours, 1, 3 & 6 months. An MRI will be
performed at the 1-month visit to detect a change in synovial vascularity and to exclude
complication.
(GAE) will reduce the severity of pain as well as global disability (resulting from the
combination of pain, stiffness and difficulty performing daily activities) caused by knee OA
and if it can be performed safely. The secondary aim is to determine if GAE can result in the
decreased necessity for ongoing conservative OA therapies such as medication therapy and
joint injections.
Participants: Twenty patients with knee osteoarthritis resulting in knee pain that is
refractory to conservative therapies, who are not planning to undergo surgery within 6
months.
Procedures (methods): This will be an open label 24-month pilot study with a small population
undergoing GAE to determine safety and efficacy. Clinical procedures and evaluations will
consist of a preoperative screening assessment to determine if the potential study subject
meets the inclusion and exclusion criteria, enrollment, surgical procedure for geniculate
artery embolization, and follow-up visits at 24 hours, 1, 3 & 6 months. An MRI will be
performed at the 1-month visit to detect a change in synovial vascularity and to exclude
complication.
Inclusion Criteria:
- Moderate to severe knee pain (visual analog scale (VAS) > 50 mm), and
- Pain refractory to at least 3 months* of conservative therapies (anti-inflammatory
drugs, or physical therapy, or muscle strengthening, or intra-articular injections),
and
- Kellgren-Lawrence grade 1, 2 or 3 on radiograph of the knee.
Exclusion Criteria:
- Current local infection, or
- Life expectancy less than 6 months, or
- Known advanced atherosclerosis, or
- Rheumatoid or infectious arthritis, or
- Prior knee surgery, or
- Uncorrectable coagulopathy including international normalized ratio (INR) > 2.5 or
platelets < 30,000, or
- Iodine allergy resulting in anaphylaxis, or
- Renal dysfunction as defined by serum creatinine >1.6 dl/mg obtained within the past
30 days.
We found this trial at
2
sites
14085 Crown Court
Woodbridge, Virginia 22193
Woodbridge, Virginia 22193
Principal Investigator: Sandeep Bagla, MD
Phone: 703-763-5224
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